Catawba Research
Catawba Research is a global contract research organization (CRO) dedicated to clinical trial management services for pharmaceutical, device, formulation development, and biotechnology companies. Founded in 2014, it emphasizes a nimble, personalized approach to study design and execution, with a focus on quality, timelines, and cost-efficiency. The company has a strong therapeutic portfolio including dermatology, women's health, pulmonary, autoimmune, and neurology, and is committed to advancing global healthcare through innovative research and strategic partnerships.
Industries
Nr. of Employees
medium (51-250)
Catawba Research
Charlotte, North Carolina, United States, North America
Products
Therapeutic-area training video library
Video-based training modules covering indication-specific assessments, measurement scales, and site procedures to support investigator and rater training.
Therapeutic-area training video library
Video-based training modules covering indication-specific assessments, measurement scales, and site procedures to support investigator and rater training.
Services
End-to-end trial management including protocol execution, site oversight, monitoring, and study closeout.
Operational support across clinical development programs, including monitoring, site management and operational staffing.
Data capture, cleaning, and delivery of submission-ready datasets and clinical study reports.
Provision of medical monitors to oversee subject safety, adjudicate clinical events, and advise study teams.
Consulting and execution support for regulatory pathways including NDA, 505(b)(2), and ANDA, and preparation of submission materials.
Site identification, activation and recruitment management leveraging internal networks and international sites to meet enrollment targets.
End-to-end trial management including protocol execution, site oversight, monitoring, and study closeout.
Operational support across clinical development programs, including monitoring, site management and operational staffing.
Data capture, cleaning, and delivery of submission-ready datasets and clinical study reports.
Provision of medical monitors to oversee subject safety, adjudicate clinical events, and advise study teams.
Consulting and execution support for regulatory pathways including NDA, 505(b)(2), and ANDA, and preparation of submission materials.
Site identification, activation and recruitment management leveraging internal networks and international sites to meet enrollment targets.
Expertise Areas
- Clinical trial management
- Clinical operations
- Regulatory strategy and submissions (NDA / 505(b)(2) / ANDA)
- Generic drug development and bioequivalence
Key Technologies
- Clinical data management systems (CDMS)
- Electronic Trial Master File (eTMF)
- AI-guided patient pre-screening
- Digital health / remote recruitment platforms
News & Updates
Catawba Research successfully completed a rosacea clinical trial enrolling over 1000 subjects across 33 sites in 22 weeks, with the entire project completed in 9 months, maintaining a 100% on-time completion record.
Catawba Research marks a decade of growth, innovation, and commitment to advancing healthcare, with over 30 regulatory approvals and a strong presence in dermatology, women's health, pulmonary, autoimmune, and neurology research.
Achieved over 30 regulatory approvals without a single change order, demonstrating high-quality trial management and compliance.
Catawba Research successfully completed a rosacea clinical trial enrolling over 1000 subjects across 33 sites in 22 weeks, with the entire project completed in 9 months, maintaining a 100% on-time completion record.
Catawba Research marks a decade of growth, innovation, and commitment to advancing healthcare, with over 30 regulatory approvals and a strong presence in dermatology, women's health, pulmonary, autoimmune, and neurology research.
Achieved over 30 regulatory approvals without a single change order, demonstrating high-quality trial management and compliance.